Manufacturing Antibody-Drug Conjugates (ADCs): Extractables Study on Single-use System Consumables

Interest in the usage of single-use systems for manufacturing antibody drug conjugates (ADC) is on the rise. Minimized exposure to toxins, cross contamination, and extensive clean-in-place procedures are some of the major benefits driving appeal.

However, the use of single-use systems in processing ADCs raises concerns about extractables and leachables (E&L), substances that may be released from plastic components under certain conditions. 

Focused on evaluating consumables in the presence of dimethyl sulfoxide (DMSO) and dimethylacetamide (DMAC), this application note outlines the materials, methods, design and results of an extractables study using ProConnex^® Flow Paths for KrosFlo^® RS tangential flow filtration systems and TangenX^® SIUS^® Gamma flat sheet cassettes.